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U.S. Department of Health and Human Services

Premarket Approval (PMA)

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Note: this medical device record is a supplement. The device description may have changed. Be sure to look at the original PMA to get an up-to-date view of this device.
 
Trade NameULTRAVIOLET-ABSORBING SILICONE POSTERIOR CHAMBER INTRAOCULAR LENSES,MODEL C11UB
Classification Nameintraocular lens
Generic Nameposterior chamber intraocular lens
Regulation Number886.3600
ApplicantBAUSCH & LOMB, INC.
PMA NumberP910058
Supplement NumberS011
Date Received01/12/2000
Decision Date04/18/2000
Product Code
HQL[ Registered Establishments with HQL ]
Advisory Committee Ophthalmic
Supplement Typereal-time process
Supplement Reason process change: packaging
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
Approval for an alternate packaging configuration comprising a different lens carrier design and a single, rather than double, autoclavable pouch.
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